Impact of L-citrulline Associated With L-arginine Supplementation on the Post-exercise Hypotension in Normotensives and Hypertensives
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Ambulatorial Blood Pressure Monitoring
Study Overview
Brief Summary
Post-exercise hypotension (PEH) is a established phenomenon as one of the non-pharmacological ways of reducing blood pressure, producing important impacts, particularly in hypertensive individuals. However, the factors involved in the magnitude and duration of this effect are relatively little studied. Thus, the bioavailability of vasodilatation mediators may maximize the duration and magnitude of PEH. In this sense, the objective of the present project will be to verify the impact of L-citrulline associated with L-arginine supplementation on the acute blood pressure response after an aerobic exercise session. Approximately 80 adults (40 normotensive and 40 hypertensive) will be selected. The sample will be submitted to measurements of body mass, height and resting blood pressure. After the minimum interval of 48 h, subjects will be randomly submitted to four experimental situations (exercise/L-citrulline, exercise/L-arginine, exercise/placebo, exercise/L-citrulline + L-arginine). The exercise sessions (40 min in treadmill at 60% of FCres) will be performed with a minimum interval of 48 h. After each session, the blood pressure of the sample will be recorded during 24 hours. For data analysis, blood pressure values will be plotted in average of the wakefulness and average of the sleep periods and average of the 24 hours. The comparisons will be made through the ANOVA (repeated measures), following the recommended assumptions. It is hoped that the results of this project will collaborate to the knowledge regarding non-pharmacological models aimed at the prevention and treatment of hypertension in normotensive and hypertensive patients.
Detailed Description
Participants After sample size calculation (see statistical analysis session), 40 hypertensives and 40 normotensive sedentaries will be recruited to this study. All volunteers (both sexes) will be adults without osteoarticular disabilities and they will need a medical authorization to physical exercise practice. Participants will be recruited from an exercise program project linked to the university that offered stretching and functional exercises sessions to the external community. The study follow the Declaration of Helsinki and the Institutional Ethics Committee approved all experimental procedures and protocols. Each participant will be fully informed of all potential risks and experimental procedures, after which, informed written consent will be signed. Table 1 shows the basics characteristics of the participants.
Study design A double-blind crossover randomized clinical trial will be conducted. After the minimum interval (48 hours), the subjects will be randomly (using a random number table - https://www.random.org/) submitted to four experimental situations (exercise/L-citrulline, exercise/L-arginine, exercise/placebo, exercise/L-citrulline + L-arginine). The participants will ingested a sachet, which contained L-citrulline malate (6 grams) or L-arginine (8 grams) or placebo (6 grams of corn starch) dissolved in water.
The substances will be ingested 120 minutes before the experimental or control session. Anthropometric measures will be taken before the rest period. The exercise session consisted of 5 min to warm up (50% of 65% HRreserve) and 40 minutes of run/walk at 60-70% HRreserve (or 12-14 ratings of perceived exertion [RPE](1) if take some beta-blocker medicines) in a treadmill. This will be followed by a progressive cooldown (5 minutes). In the control session, the participants will be remained seated in a quiet room for 40 min.
After the exercise/control sessions, the blood pressure will be measured every 10 minutes over the course of 60 minutes and the heart rate variability will be recorded continuously for 60 minutes (laboratorial phase). Then, 15 minutes will be given to the participants to take a shower and change the clothes before the ambulatory blood pressure device be attached on their arm. The ambulatory blood pressure will be recorded over 24 hours. In the next day, the participants will be asked to return to the laboratory to remove the device.
Anthropometry The weight will be measured by the digital anthropometric scale (Urano, OS 180A, Canoas, Brasil), with accuracy of 0.1kg and height will be measured by stadiometer with accuracy of 0.1cm, in accordance with the procedures described by Gordon et al (2). The body mass index (BMI) will be defined as the body mass (kg) divided by the square of the body height.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Hypertensive and Normotensive, without osteoarticular disabilities and medical authorization to physical exercise practice.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Ambulatorial Blood Pressure Monitoring
Time Frame: 24 hours
The ambulatorial blood pressure measurements will be taken with oscillometric device (Dyna-MAPA - São Paulo, Brazil) attached on the left arm. The participants will received instructions to keep the arm stand during the measures. The monitor will be setting to register the systolic and diastolic blood pressure and heart rate every 20 minutes during "daytime" (08:00am to 11:00pm) and every 30 minutes during "night-time" (11:00pm to 08:00am) to reduce sleep disturbs. The device screen will be electronically blinded to avoid feedback. The metric measures will be reported by millimeters of mercury (mmHg).
Secondary Outcomes
No secondary outcomes reported
Investigators
Juliano Casonatto
Professor, Clinical Research
Universidade Norte do Paraná